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Be Part of Research - Trial Details - Dexcom Hybrid Closed Loop Insulin Pump Study in Type 1 Diabetes

Dexcom Hybrid Closed Loop Insulin Pump Study in Type 1 Diabetes

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Diabetes Mellitus
Diabetes Mellitus, Type 1


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Treatment of Type 1 diabetes requires daily insulin therapy given by either multiple daily injections or by continuous infusion via a pump. The insulin dose is calculated taking into consideration blood glucose levels, food intake and activity levels, aiming to avoid high and low readings.

The Tandem t:slim X2™ insulin pump has recently become available in NHS Scotland and can link with the Dexcom G6 continuous glucose monitoring (CGM) system.

The Tandem Control IQ hybrid closed loop system is made up of the Tandem insulin pump communicating wirelessly with the Dexcom G6 CGM. The algorithm within the pump then automatically controls the background (basal) insulin infusion rate. Manually delivered bolus insulin is still required for meals. This system is designed to finely tune insulin delivery and increase the amount of time that glucose is in the target range, reducing hypoglycaemia and hyperglycaemia.

Insulin pumps are funded by NHS Scotland, but the Dexcom G6 continuous glucose monitoring system is not, so this hybrid closed loop system is not currently routinely available in NHS Scotland.

The purpose of this study is to gain experience of this system and investigate how effective and acceptable the hybrid closed loop system is for people in Scotland. Participants will be provided with the Dexcom G6 CGM device to link to their current pump to create the hybrid closed loop system for the duration of the study.

30 people with Type 1 diabetes who have been using the Tandem pump for at least one month will be invited to participate.

The study will include a screening visit, a 30 day run-in period, 52 week treatment period and 12 week follow-up period. Diabetes control will be measured using HbA1c and downloaded information from the hybrid closed loop system. Participants will also complete questionnaires and a reflective diary.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2023 Aug 2025

OBSERVATIONAL

Intervention Type : DEVICE
Intervention Description : The Tandem Control IQ hybrid closed loop insulin delivery system is made up of an externally worn Tandem insulin pump which communicates wirelessly to the Dexcom G6 CGM worn as a patch on the skin. The CGM measures glucose levels transmitting them into the computer within the pump. The computer then calculates how much insulin is required then dose delivery completes the cycle. The Control-IQ™ advanced technology adjusts insulin delivery to avoid glycaemic excursions, while still allowing the user to manually bolus at mealtimes.




You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Professor John McKnight
    Edinburgh
    Lothian
    EH4 2XU


The study is sponsored by NHS Lothian and is in collaboration with DexCom, Inc..





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Read full details for Trial ID: NCT05059860
Last updated 13 November 2024

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